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In your studies 'Drug Regulator Affairs'

©Volker Lannert / Universität Bonn

Master's thesis


As part of the continuing education Master's degree programme, Master's theses are written on relevant topics in the field of 'Drug Regulatory Affairs' using scientific methods. The topics are highly topical, diverse and the results are both of interest in a scientific context and relevant to many areas of activity in 'Drug Regulatory Affairs'.

Here you will find all Master's theses written since the year 2000, including the title and a summary. In this collection, many Master's theses can also be viewed and downloaded in full text.

Further information on Master's theses (e.g. registration, processing) can be found in our ‘Master's thesis guidelines/Leitfaden für die Anfertigung einer Masterarbeit’ (in German) and in the ‘Information leaflet - Master's thesis’ at

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Do you have any questions or are you interested in the full text of a Master's thesis that is not listed here?
Please feel free to contact me.

Dr. Jasmin Fahnenstich

Dr. Jasmin Fahnenstich

Study programme manager

Phone: +49 (0) 228 - 9268 6806

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Master's thesis

The collection of Master's theses can be searched and sorted by entering keywords.

Year Name Title Full text Summary
2016 Annette Fries Regulatory Intelligence: How public information available in the internet can support a development strategy ***
2016 Wolfgang Gulbins Between Standardisation and Flexibility - Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe ***
2016 Tanja Hanikel Registration procedure for medical devices in the Russian Federation – under consideration of the new EEU regulations
2016 Thomas Haupt Data and knowledge management optimization by introduction of a new Collaboration Tool (Microsoft SharePoint) in the Regulatory Affairs Department of a mid-sized pharmaceutical company
2016 Dr. Niklas Jänich Paediatric Drug Development from a Labeling Perspective - A detailed view on the European Summary of Product Characteristics with an exemplary comparison to the US Prescribing Information ***
2016 Helene Janzen Forced degradation studies - comparison between ICH, EMA, FDA and WHO guidelines and ANVISA's resolution RDC 53/2015 ***
2016 Regina Kaiser Recent Developments on the EU-Regulatory Approach in mobile Health regarding mobile Health Apps which can be "medical Apps" or "non medical Apps" ***
2016 Dr. Anja Kassner Harmonization of Regulated Product Submissions for Medical Devices - International Medical Device Regulators Forum Table of Content concept
2016 Martina Kirsch Epigenetic Research bridges Clinical Research Gaps in Schizophrenia: Epigenetic Biomarker Development and Informed Consent Process Considerations in Clinical Trials
2016 Almut Koch The worldwide challenge of antibiotic resistance. Strategies in Europe and USA from a regulatory point of view
2016 Mariana Lagos Quintana Oligonucleotide-based Therapeutics, Development and Regulatory Challenges ***
2016 Katrin Lambrecht Pyrrolizidine alkaloids - Impact of the public statements made by EMA and national health authorities on the pharmaceutical industry ***
2016 Martina Luh Data integrity: Presentation of Measuring values in Module 3: Challenges for Regulatory CMC
2016 Dr. Julia Katharina Mack Revision of Council Directive 90/167/EEC – current and future legal situation regarding medicated feed in the European Union as compared to the United States of America and Canada ***
2016 Dr. Qian Mao Breakthrough Therapy Designation: Challenges and Opportunities for Innovative Drug Development – A Three-Year Review after PDUFA V ***
2016 Juliane Merz Investigation on Melatonin as a Substance: A Closer Consideration of Differences and Similarities in the Legal Principles Applicable to Melatonin Containing Products at the International, European and National Level - Including a potential regulatory strategy to obtain a marketing authorisation for Germany
2016 Christiane Metje Benefits and success of outsourcing in DRA
2016 Dr. Caroline Mörler Produktinformationen in Deutschland: Welche europäischen sowie nationalen Verfahren und gesetzlichen Vorgaben nehmen Einfluss auf die Gestaltung von Fach- und Gebrauchsinformationen - eine Übersichtsarbeit
2016 Dr. Robert Mühlbacher Diversity of regulatory requirements for the approval of biosimilars in the LATAM region: Comparison of the WHO guidance with the available guidelines/regulations in Chile, Brazil and Colombia ***
2016 Kathrin Mundt National piloting activities in preparation of the new Clinical Trials Regulation Regulation (EU) No 536/2014 ***
  • Total: 959